solriamfetol for the treatment of multiple sclerosis fatigue

Conditions: Multiple Sclerosis; Multiple Sclerosis Fatigue

Summary: fatigue is a prevalent and disabling symptom in multiple sclerosis (ms), affecting up to 90% of patients. current treatments, including off-label prescriptions of wake-promoting agents, have shown limited effectiveness. previous research indicates that these agents may be beneficial specifically for ms patients with concomitant excessive daytime sleepiness. this study uses a randomized, double-blind, placebo-controlled crossover design. participants will undergo a 10-day lead-in with he medication/placebo, followed by two four-week treatment periods separated by a one-week washout. outcomes will be measured primarily using the modified fatigue impact scale (mfis), with additional exploratory measures collected via a smartphone app that assesses fatigue through keystroke dynamics. this novel approach to fatigue measurement aims to capture real-time variations and provide more granular data than traditional self-report questionnaires.


Eligibility criteria:
inclusion criteria: * male or female, 18 to 60 years of age, inclusive. * medically stable on the basis of physical examination, medical history, and vital signs * must meet mcdonald 2017 diagnostic criteria for multiple sclerosis based on the pi review of the medical records * must complain from fatigue as one of their main symptoms and have a screening mfis score of 33 or more * a screening ess score of 10 or more * must be ambulatory (able to walk at least 20 feet using bilateral assistance) * must have internet and email access and the ability to use a computer or tablet, or smartphone * own an android smartphone or an iphone * consent to use a medically acceptable method of contraception for the duration of the study * willing and able to comply with the study design schedule and other requirements * willing and able to provide written informed consent exclusion criteria: * history of coronary artery disease or congestive heart failure * uncontrolled hypertension at screening (history of high blood pressure and screening systolic blood pressure \>160 or diastolic blood pressure\>100) * a known history of uncontrolled diabetes (the last known hemoglobin a1c level above 7.0%), high bmi (\>35), or hyperlipidemia (last known total cholesterol \>240 mg/dl, or ldl cholesterol level \>160 mg/dl) * receiving drugs/treatments that increase blood pressure or heart rate (based on the pi review of the medications/treatments) * a history of cerebrovascular disease or stroke * a medical or neurological disorder other than ms, that was associated with excessive sleepiness. * a history of phenylketonuria or hypersensitivity to the phenylalanine-derived product * a history of alcohol or drug abuse within the past two years * a history of psychosis, or bipolar disorder * a history of cardiac arrythmias * the use of any product with stimulating or sedating properties, unless they have been on a steady dose for at least a month prior to the screening visit and agree to stay on the same dose over the course of the study * use within 14 days of a monoamine oxidase (mao) inhibitor drug * pregnant or lactating * use of medications used for the treatment of fatigue (including amantadine, modafinil, armodafinil, and amphetamine-like stimulants) in the past two weeks of the screening visit * a known history of moderate or severe kidney dysfunction (estimated glomerular filtration rate of less than 60 ml/min)

Keywords: multiple sclerosis fatigue daytime sleepiness